“We are excited to have secured patent protection for our ground-breaking CarpX device,” Dr. Aklog said. “The patent grant is especially timely as we continue to advance CarpX towards commercialization through several key milestones, such as the recent successful completion of all procedures in the CarpX clinical safety study and our upcoming FDA 510(k) re-submission. We believe this patent creates significant barriers to entry for current and future competitors in the minimally invasive and percutaneous carpal tunnel release space, and will provide us with the commercial freedom to operate as we pursue the billion-dollar U.S. market opportunity that CarpX represents. It anchors PAVmed’s robust and expanding intellectual property portfolio, which includes over 75 patents and patent applications across 10 families.”
U.S. Patent 10,335,189, entitled “Systems and Methods for Percutaneous Division of Fibrous Structures,” includes broad independent claims covering a device with a catheter, an expandable member such as a balloon, and a cutting element such as a pair of bipolar radiofrequency electrodes. The claims are not limited to CarpX or carpal tunnel syndrome and cover device embodiments which can be developed to treat a broad spectrum of conditions, such as plantar fasciitis and compartment syndromes, where compression by fibrous tissue causes pain or other debilitating symptoms. The CarpX IP portfolio also includes multiple international and follow-on patent applications.
CarpX is a minimally invasive device developed to treat carpal tunnel syndrome while reducing recovery times. CarpX is designed to closely mimic the anatomic results of invasive carpal tunnel surgery, but much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to percutaneous and minimally invasive revolutions in the treatment of other conditions. The balloon catheter device is designed to be inserted under the scarred ligament in a minimally invasive fashion, while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. The device design provides physicians with ongoing feedback to optimize the safety and completeness of the procedure.
PAVmed Inc. is a highly differentiated, multiproduct medical device company employing a business model designed to advance products to commercialization much more rapidly and with significantly less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation. PAVmed’s diversified pipeline of products address unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its five lead technologies provide approaches to carpal tunnel syndrome (CarpX), precancerous conditions of the esophagus (EsoGuard/EsoCheck), vascular access (PortIO), pediatric ear infections (DisappEAR) and medical infusions (NextFlo). The company is also developing products in other areas, such as catheters and tissue ablation, while seeking to further expand its pipeline through engagements with clinician innovators and academic medical centers.